Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04842812
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2021-04-04
Brief Title:
Engineered TILsCAR-TILs to Treat Advanced Solid Tumors
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Engineered TILsCAR-TILs With PD1 Knockout and Anti-PD1CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tumor infiltration lymphocytes TILs have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens followed by transfusion into the patients The safety tolerance and preliminary clinical efficacy of the TILs will be evaluated
Detailed Description:
1 Choose appropriate patients with advanced lung or other cancers with written consent for this study
2 Perform biopsy or collect cancerous effusion in thorax or abdomen to obtain TILs by standard protocol
3 Grow TILs and engineered the tumor-effective TILs with CRISPRA-CAS9 technique to knockdown PD1 and electronic-transfection strategy to express scFvs that target PD1 and CTLA4 amplify the engineered T cells as needed test the quality and killing activity of the TILs and then transfuse them back the patients via systemic or local injections via standard protocol and follow up closely to collect related parameters as needed
4 To enhance the killing capability tumor-noneffective TILs have also been genetically engineered to express various CARs targeting HER2MesothelinLewis-YPSCAMUC1 GPC3AXLEGFRClaudin182B7-H3ROR1GD2AXLClaudin6-DAP10 with knockdown of PD1HPK1 as appropriate
5 Evaluate the clinical results as needed
2 Perform biopsy or collect cancerous effusion in thorax or abdomen to obtain TILs by standard protocol
3 Grow TILs and engineered the tumor-effective TILs with CRISPRA-CAS9 technique to knockdown PD1 and electronic-transfection strategy to express scFvs that target PD1 and CTLA4 amplify the engineered T cells as needed test the quality and killing activity of the TILs and then transfuse them back the patients via systemic or local injections via standard protocol and follow up closely to collect related parameters as needed
4 To enhance the killing capability tumor-noneffective TILs have also been genetically engineered to express various CARs targeting HER2MesothelinLewis-YPSCAMUC1 GPC3AXLEGFRClaudin182B7-H3ROR1GD2AXLClaudin6-DAP10 with knockdown of PD1HPK1 as appropriate
5 Evaluate the clinical results as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None